sacral nerve stimulation

Medtronic Touts 5-Year Data on InterStim Neuromod Device for OAB

Medtronic today touted 5-year results from the InSite study of its InterStim neuromodulation treatment for overactive bladder syndrome.  InterStim is designed to stimulate the sacral nerve to treat OAB, meaning urinary urge incontinence and/or urgency-frequency. The InSite study enrolled 340 patients, of which 272 were implanted with an InterStim device, comparing treatment with the device with standard drug therapy. The primary safety endpoint was to “demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 33%” at 5 years, according to ClinicalTrials.gov. The primary efficacy endpoint was superior improvement in OAB symptoms at 6 months. Read more.

Source: MassDevice Today, July 17, 2017

business buildings

RDD Pharma Receives Orphan Designation for RDD-0315 in Spinal Cord Injury Patients

RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the European Medicines Agency’s Committee for Orphan Medicinal Products has granted orphan designation for RDD-0315, an investigational drug for the treatment of fecal incontinence in patients with spinal cord injury.   The committee recognized that RDD-0315 may be of significant benefit to spinal cord injury patients affected by fecal incontinence. “We are pleased the EMA recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients,” stated Jason Laufer, Chief Executive Officer, RDD Pharma.  ‘We have the potential to positively impact the health, well-being and quality of life in this patient population. ‘  Read more.

Source: PRNewswire, July 5, 2017

 

drugs for overactive bladder (OAB)

GTx Announces Preliminary Results with Enobosarm

GTx, Inc. (Nasdaq: GTXI) today announced release of preliminary clinical data from its ongoing, open-label, Phase 2 clinical trial of enobosarm 3 mg (GTx-024) in postmenopausal women with stress urinary incontinence (SUI). An abstract entitled “Kegels In A Bottle”: Preliminary Results Of A Selective Androgen Receptor Modulator (GTx-024) For The Treatment Of SUI In Post-Menopausal Women, summarizing clinical data from the first seven patients completing 12 weeks of treatment with enobosarm, is now available on the International Continence Society’s website. This proof-of-concept clinical trial is the first of its kind to evaluate an orally-administered selective androgen receptor modulator (SARM) for SUI. Read more.

Source: BusinessWire, June 12, 2017

doctor and patient

Third Randomized Controlled Trial (RCT) of the Vesair™ Bladder Control System For the Treatment of Stress Urinary Incontinence Delivers Promising Results

Solace Therapeutics, Inc., today announced that data from a multicenter 221 patient randomized controlled trial has met study endpoints with statistical significance. Dr. Eric Rovner will be presenting a poster of the results from the SUCCESS Clinical Trial at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) meeting in Scottsdale, Arizona on Thursday, March, 2nd.  This is the Company’s third randomized controlled trial to evaluate the safety and efficacy of the Vesair Bladder Control System; a novel, office-based, reversible treatment designed to reduce or eliminate urine leakage in female patients with Stress Urinary Incontinence (SUI).  Read more.

Source: Business Wire, March 1, 2017

microbiologist at laboratory work

BioLife Products Embedded in Cook MyoSite Phase 3 Cell Therapy Trial for Stress Urinary Incontinence

BioLife Solutions, Inc.(BioLife, a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media, announced that its media products are embedded into the autologous cell therapy being developed by Pittsburgh-based Cook MyoSite, a subsidiary of the Cook Group, for treatment of female stress urinary incontinence.  Read more.

Source: PharmaBiz.com, July 19, 2016